Abstract
Comparison of bupropion and hydroxybupropion steady state plasma concentrations between bariatric patients and non-bariatric patients using the prolonged-release combination formulation of naltrexone/bupropion Background In patients undergoing bariatric-metabolic surgery (BMS) with weight recurrence, it was found that naltrexone/ bupropion (NB) leads to additional weight loss. BMS results in anatomical and physiological changes, which might influence the absorption of NB. At the moment, there is no information about the changes in pharmacoki-netics of NB prolonged-release tablets (Mysimba) after BMS. Objective The primary objective is to study bupropion and the major active metabolite hydroxybupropion absorption/ exposure by measuring steady state trough levels in bariatric patients and to compare these with steady state trough levels in obese patients on NB therapy who did not undergo BMS. Design and methods In this prospective multicentre study, blood samples to determine bupropion/hydroxybupropion trough levels will be drawn when patients use their highest tolerated maintenance dose for at least one week to ensure steady state plasma levels. The dosage can range from one tablet (8 mg naltrexone hydrochloride/90 mg bupropion hydrochloride) once daily to two tablets twice daily. Mann-Whitney U test is used to compare the mean bupropion/hydroxybupropion trough levels between NB users with and without BMS. Results Thus far we collected blood samples of 18 patients for this interim analysis, 4 with BMS and 14 without BMS. Lower hydroxybupropion trough levels are seen in patients with BMS (median: 453 ug/L) compared to patients without BMS (median: 976 ug/L), although this difference was not statistically significant (P = 0.089). This might be caused by the small number of patients in this study. For bupropion we found no difference between the groups. Conclusion In a small group of patients we observed lower hydroxybupropion steady state trough levels in patients with BMS, although this difference wat not statistically significant. More data are needed to confirm the trend towards lower hydroxybupropion trough levels in patients with BMS.
| Translated title of the contribution | Comparison of bupropion and hydroxybupropion steady state plasma concentrations between bariatric patients and non-bariatric patients using the prolonged-release combination formulation of naltrexone/bupropion |
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| Original language | Dutch |
| Pages (from-to) | 21-25 |
| Number of pages | 5 |
| Journal | Pharmaceutisch Weekblad |
| Volume | 159 |
| Issue number | 31-32 |
| Publication status | Published - 2 Aug 2024 |